The FDA ESG offers WebTrader users an additional capability: the WebTrader Hosted Solution (WTHS).
What is WTHS?
WTHS is a web-based solution that will eliminate the need for installing JRE (Java Runtime Environment) on the user’s machine. The benefits of WTHS are:
- WTHS eliminates the need for JRE installation and maintenance for WebTrader users’ computers
- WebTrader users can make submissions from both Windows and Mac operating systems
- Users may make submissions from almost any Web Browser
For more information on WTHS, please read below and visit WTHS FAQs
Do I use WTHS instead of WebTrader?
No, WTHS is an alternative to utilizing the computer-based application from a specific computer for making submissions to FDA. WTHS is an additional FDA service capability that eliminates the need for users to update Java in order to make WebTrader submissions. It also provides submission process redundancy in case of a user not being able to access the JRE computer.
Users opting for WTHS will have an additional login (in addition to WebTrader login).
The WTHS Tutorial outlines how the WTHS and WebTrader account login and submission process works.
Are there any requirements to utilize WTHS?
The following rules apply for utilizing WTHS
- WTHS login session will have a limit of 60 minutes per login
- WTHS option is recommended for submissions smaller than 250MB
- Only one login session is allowed per user
- Only one WTHS account is allowed per user. Users that have multiple WebTrader accounts will only be issued one WTHS account
How long will it take my file to get to the FDA Gateway using the WTHS?
The following data was submitted to the FDA Gateway as part of Industry Testing. Times for submissions vary by file size, Internet speeds and Geographic location:
|City and State||Internet Bandwidth (Mbps)||Minutes to Upload by File Size|
|Upload||96 MB||214 MB||415 MB||627 MB||875 MB|
|San Francisco, CA||12||25||n/a||n/a||n/a||n/a|
How do I request a WTHS account?
- Existing WebTrader users: Send an email to firstname.lastname@example.org requesting access to WTHS. Please include your WebTrader User Id in the email request.
- New WebTrader users: Perform the steps outlines in the WebTrader checklist: http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm114831.htm